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TGA tests wide range of products
In response to reported concerns during the past Australian summer that sunscreens were failing to provide adequate sun protection, the TGA undertook laboratory testing of 31 commonly used products, including lotions, creams and aerosol sprays, sourced from pharmacies and supermarkets.
We found that all products tested contained the correct levels of ingredients, as specified on their labelling, and complied with the Australian regulatory guidelines for sunscreens for content of sun protection ingredients (90-120% of the labelled claim).
For a full list of products tested see the table below.
Also, following concerns raised through the use of aerosol spray products, we undertook preliminary testing to investigate their delivery rates. We found the amount of sunscreen delivered per second differed between brands. Given this, it is important consumers follow the labelling instructions to 'apply liberally' to ensure proper coverage of the sunscreen.
We plan to undertake additional investigations into aerosol products as part of our ongoing review of all sunscreen products.
With more than 24 million people in Australia there are many millions of applications of sunscreen each year and - given the widespread use - the rate of reported problems is low. Between 1 January and 31 December 2016 the TGA received a total of 27 reports of adverse reactions to sunscreens. Of these 15 were reports of allergic reactions (rash) and 12 reports of a product not being effective.
It is important for consumers to understand that sunscreen is only one of the protections people should take to protect themselves from sunburn and skin cancer, others include limited exposure to direct sun, proper clothing and shelter.
The Cancer Council and medical colleges have emphasised the importance of applying sunscreens liberally and regularly, as these products are commonly under-applied.
Topically applied sunscreens are also removed from the skin due to sweating, washing and being wiped by towel or clothing. Accordingly, they must be labelled with instructions to apply generously to the skin 20 minutes before skin exposure, then reapply frequently, and after swimming or towelling.
The TGA has started an additional project to check the compliance of all sunscreens listed on the Australian Register of Therapeutic Goods.
This review will check a representative sample of sunscreens supplied in Australia to ensure they are safe, of good quality and meet regulatory requirements.
The review will focus on sunscreen formulations, their manufacture and labelling, as well as other safety and quality aspects that can affect the safe use of sunscreens.
We will publish a summary of the review outcomes at the completion of the project in late 2017.
Further information about the regulation of sunscreens in Australia
In Australia, most sunscreens are regulated by the TGA as therapeutic goods. These products are referred to as therapeutic sunscreens. Sunscreens not regulated by the TGA include cosmetics sunscreens, and sunscreens with an SPF under 4.
Therapeutic sunscreens are required to meet the Australian regulatory guidelines for sunscreens.
These requirements include:
- TGA licencing or approval of manufacturers
- compliance with the TGA's Good Manufacturing Practice (GMP) requirements
- the use of TGA-approved ingredients
- compliance with the relevant standard: AS/NZS 2604:2012 Sunscreen products-Evaluation and classification.
|Product name||AUST L Number||Active ingredients (see bottom of table for alphabetical key)|
|Banana Boat Ultra very high protection clear sunscreen spray SPF 50+||206508||B, D, G, I|
|Cancer Council active oil-free clear sunscreen SPF50+||226411||B, D, E, G, I|
|Cancer Council Finding Dory watersport sunscreen SPF50+||274199||B, D, E, G, I|
|Cancer Council kids sunscreen SPF50+||274965||B, E, G, J|
|Cancer Council Peppa Pig kids sunscreen SPF50+||274967||B, E, G, J|
|Cancer Council ultra sunscreen SPF50+||274938||B, D, G, I|
|Cetaphil Suntivity kids very high protection liposomal lotion body & face SPF50+||208997||A, C, F, H, J|
|Coles everyday sunscreen SPF50+||274308||B, D, G, I, K|
|Coles face sunscreen lotion SPF30||273859||B, E, G, I ,J|
|Coles kids sunscreen SPF50+||273860||B, D, G, I, K|
|Ego Sunsense sport SPF50+||196203||C, J, K, L|
|Ego Sunsense ultra SPF50+||194260||A, C, H, J, L|
|Hamilton active family very high protection SPF50+||222904||B, D, G, I|
|Hamilton everyday face very high protection lotion SPF50+||240532||B, E, G, J|
|Hamilton sensitive very high protection SPF50+||222688||B, E, G, J|
|Le Tan active Kids very high protection sunscreen lotion SPF50+||275363||B, E, G, J|
|Le Tan coconut spray SPF30+||171149||B, E, G, H|
|Le Tan invisible sports spray very high protection lotion SPF50+||274354||B, D, G, I|
|Neutrogena ultra sheer dry touch sunscreen lotion SPF 50+||202300||B, D, G, I, K|
|Nivea sun kids caring roll-on sun lotion SPF 50||208776||A, E, F, M|
|Ombra kids clear sunscreen spray SPF50+||223727||B, D, E, G, I|
|Ombra kids coloured roll-on sunscreen lotion SPF 50+||243093||B, D, G, I, K|
|Ombra ultra sport sunscreen lotion SPF50+||276546||B, D, G, I, K|
|Oz Guard Batman sunscreen lotion SPF50+||262513||B, D, E, G, I|
|Oz Guard Superman sunscreen lotion SPF50+||262512||B, D, E, G, I|
|Oz Guard Wonder Woman sunscreen lotion SPF50+||262528||B, D, E, G, I|
|Surf life saving daily sunscreen SPF50+||276025||A, B, E, G|
|Surf life saving sport very high protection sunscreen SPF50+||275705||B, D, E, G, I|
|Woolworths everyday sunscreen SPF50+||280978||B, D, G, I|
|Woolworths active sport cooling sunscreen spray SPF50+||246780||B, D, E, G, I|
|Woolworths kids sunscreen SPF50+||237894||B, E, G, J|
A - Bemotrizinol
B - Butyl methoxy dibenzoylmethane
C - Diethylamino hydroxybenzoyl hexyl benzoate
D - Homosalate
E - 4-Methylbenzylidine camphor
F - Methylene bis-benzotriazolyl-tetramethylbutylphenol
G - Octocrylene
H - Octyl methoxy-cinnamate
I - Octyl salicylate
J - Octyl triazone
K - Oxybenzone
L - Titanium Dioxide (content not determined)
M - Zinc Oxide (content not determined)